To each trial we allocate a dedicated team, comprising about 20 expert staff from various disciplines, including
- Medical – an experienced Principal Investigator (PI) and Research Physician
- Project Management – usually an experienced PhD
- Recruitment and Screening
- Pharmacy – with one or more Qualified Persons (QPs)
- Statistics and Data Management
- Quality Assurance (QA)
The sponsor thus has contact with a dedicated specialist in each aspect of the trial. Our team of night staff, including a Resident Medical Officer, complement the trial team to offer a 24/7 service.
The PI has legal responsibility for the clinical parts of the trial and, with the Research Physician, liaises directly with the Sponsor’s Medical Monitor over matters of safety, including eligibility criteria. The Clinical Project Manager (CPM) coordinates support services for the trial, and is the main point of contact with the sponsor.
Each ward team comprises about 12 Research Nurses and Clinical Trial Associates (CTAs). The Team Leader and Deputy liaise with the sponsor’s monitors. The Head of QA, Head of Pharmacy Production or a designated QP liaises with the sponsor’s auditors over GMP issues. Designated staff from each speciality are available to the sponsor to liaise directly over technical matters.
The trial team is supported by industry-leading experts within HMR. Our Medical Director has written more than 150 papers and articles on clinical pharmacology, drug development and research ethics, and numerous company reports and reviews. Our Chief Medical Adviser is also the author of more than 150 publications on general and specialist clinical pharmacology.